Chapter 9. Module 9. User-defined Query Category Types

Table of Contents

9.1. Tests & Requirements
9.2. Begin Module 9. User-defined Query Category Types.
9.3. Retrieve an existing data record in DFexplore.
9.4. Apply a user-defined Category query.
9.5. Add a reason for Data Value to explain entered data.
9.6. Edit an existing query.
9.7. Delete a user-defined Query Category that is used by an existing query.
9.8. Delete a user-defined Category query.
9.9. End Module 9. User-defined Query Category Types.

9.1. Tests & Requirements

  1. Retrieve an existing data record in DFexplore.

  2. Apply a user-defined Category query.

  3. Add a reason for Data Value to explain entered data.

  4. Edit an existing query.

  5. Delete a user-defined Query Category that is used by an existing query.

  6. Delete a user-defined Category query.

Estimate of Time Required: 30 Minutes

9.2. Begin Module 9. User-defined Query Category Types.

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click 9. User-defined Query Category followed by Begin to begin this module.

9.3. Retrieve an existing data record in DFexplore.

  1. Start DFexplore, login as data_coordinator and choose 254 Acceptance Test Study as described in Section 1.7, “How to start DFexplore.

  2. Select Select > Change Mode & Level. Within the dialog, set:

    • Mode = Validate

    • Save level = 1 - Level 1

    • Check (enable) Enable edit checks

    Click OK to apply these settings.

  3. Double-click the folder for Site 99 and then double-click subject 99007 to open the subject binder. Locate 0: Screening Visits in the list of visits for subject 99007, and double-click this entry to open task records for this subject. Press Tab to advance through the fields until Screen 2, Reading 1 systolic blood pressure becomes the current field.

9.4. Apply a user-defined Category query.

  1. With Screen 2, Reading 1 systolic blood pressure as the current field, select Field > Add Query or click to open the Add Query dialog. In the dialog, confirm that Monitor, Test and Clinical QC are present in the Category pull-down list. Set:

    • Category = Test

    • Use = External

    • Type = Clarification

    • Status = New query

    • Detail = This value is out of our reference range. Please review.

  2. Click OK to apply the query to the Screen 2, Reading 1 systolic blood pressure field. Note that the field becomes blue. Examine the details in the Query window that appears near the bottom left of the screen.

  3. Press Tab to advance through the remaining fields on the page without making any changes. Press Tab to advance to the save buttons at the bottom of the data screen. Click Incomplete to save the page.

9.5. Add a reason for Data Value to explain entered data.

  1. With BLOOD PRESSURE SCREENING VISITS as the active page, press Tab to advance through the fields until Screen 2, Reading 1 systolic blood pressure becomes the current field. Select Field > Add Reason For Data Value or click to open Reason for Data Value dialog.

  2. In the Reason field, enter The value 180 mmHg for systolic blood pressure has been confirmed. Clinical significance is being evaluated..

  3. Click OK to apply the reason to the Screen 2, Reading 1 systolic blood pressure field. Note that this field is the current field and the field becomes orange. Examine the details in the Reason window that appears near the bottom left of the screen.

    [Note]Note

    If a user-defined Category Code is defined with auto-resolution in DFsetup, adding a reason to a field that has a query with such a category will change the query status from outstanding to pending.

  4. From the Screen 2, Reading 1 systolic blood pressure field, press Tab to advance through the remaining fields on the page without making any changes. Press Tab to advance to the Save buttons at the bottom of the data screen to make them active. Click Final to save the page.

9.6. Edit an existing query.

  1. Select View > Queries. Select Show > Pending Queries to display all pending queries for Site 99 - Hospital #99.

  2. Double-click entry for subject 99007, Screening Visits: Form 1 to be taken directly to the page and the pending field.

  3. In Data View, select Select > Change Mode & Level. In the dialog, set:

    • Mode = Validate

    • Save level = 2 - Level 2

    • Check Enable edit checks

  4. Click OK to apply and close the Change Mode & Level dialog. The current field is Screen 2, Reading 1 systolic blood pressure.

  5. Select Field > Edit Query or click . In the dialog,

    • Set Use as Internal

    • Delete the existing text in the Detail field

    • Enter See Reason for Data Value. in the Note field

    Click OK to apply the edits.

  6. From the Screen 2, Reading 1 systolic blood pressure field, press Tab to advance through the remaining fields on the page without making any changes. Press Tab to advance to the save buttons at the bottom of the data screen to make them active. Click Final.

  7. Select File > Exit to close and exit DFexplore.

9.7. Delete a user-defined Query Category that is used by an existing query.

  1. Start DFsetup, login as data_manager and choose 254 Acceptance Test Study as described in Section 1.8, “How to start DFsetup.

  2. Choose Normal Access and click OK.

  3. Select View > Query Category Map.

  4. In the Query Category Map dialog, locate the entry that has Code 30 and Label Test. Click the entry to highlight it, then click Delete. Click Save and Done.

  5. Select File > Exit to close DFsetup.

9.8. Delete a user-defined Category query.

  1. Start DFexplore, login as data_coordinator and choose 254 Acceptance Test Study as described in Section 1.7, “How to start DFexplore.

  2. Double-click the folder for Site 99 - Hospital #99 to display a list of available subjects. Double-click subject entry 99007 in the subject list to open the subject binder. Locate the 0: Screening Visits visit for subject 99007 and double-click this entry. Press Tab to advance through the fields until Screen 2, Reading 1 systolic blood pressure becomes the current field. Examine the details in the Query window. If an existing query contains a user-defined category, and that category definition has been removed from DFsetup, the query in DFexplore displays Query Category Code 30.

  3. Select Field > Delete Query or click .

  4. Click OK to perform the query deletion.

  5. Click Delete in the confirmation dialog.

  6. Press Tab to advance through the remaining fields on the Blood Pressure Screening Visits page until the save buttons at the bottom of the screen become active. Click Final.

  7. Click File > Exit to exit DFexplore.

9.9. End Module 9. User-defined Query Category Types.

  • Return to the DFATK application. Click End to confirm successful completion of Module 9. User-defined Query Category.